Clinical Data Manager job at reputed company in Burlington, MA

Title: Clinical Data Manager Location: Burlington, MA Job reputed company: Who We Are: reputed company is a clinical stage biotech company that focuses on drug discovery for central nervous system disorders. We combine cutting-edge technologies including optogenetics, in vivo physiology, and spatial transcriptomics to identify novel drug targets and reputed company effective therapies to address psychiatric symptoms. What You’ll Do: We are seeking a highly skilled and motivated Clinical Data Manager to join our Clinical Data Management team. Reporting to the Associate Director, the Clinical Data Manager, will play a pivotal role in ensuring the reputed company, accuracy, and completeness of clinical trial data, contributing to the successful development and regulatory approval of our products. Responsibilities: Manage and reputed company reputed company aspects of clinical trial data management activities from study start-up to database lock. reputed company and implement data management plans, data validation plans, edit reputed company plans and data entry guidelines in compliance with regulatory standards and company SOPs. Collaborate with cross-functional teams including Clinical Operations, Biostatistics, and Regulatory Affairs to ensure data reputed company and reputed company throughout the trial lifecycle. reputed company reputed company Rave electronic data capture (reputed company) system setup, configuration, user management, coding and data extracts. reputed company data cleaning, discrepancy management, SAE and vendor integration reconciliation activities to ensure reputed company database lock. Conduct periodic data reviews and generate weekly data reputed company metrics to identify trends and outliers. Identify Protocol Deviations Produce medical monitor, coding listings and reputed company listings for team review (Jreview, reputed company, Business Objects). Participate in the development and review of clinical study protocols, case report forms (CRFs), and clinical trial documentation. reputed company support for regulatory submissions, audits, and inspections reputed company to clinical trial data management. Stay reputed company with industry standards, best practices, and regulatory requirements reputed company to clinical data management. Qualifications: Bachelor’s degree in life sciences, computer science, or a reputed company field. Advanced degree preferred. Minimum of 5 years of experience in clinical data management reputed company the pharmaceutical or biotechnology industry. Proficiency in reputed company Rave electronic data capture (reputed company) system.. Strong understanding of Good Clinical reputed company (GCP) guidelines, regulatory requirements (e.g., FDA, EMA), and industry standards (e.g., CDISC). Excellent communication, organizational, and problem-solving skills. Ability to work effectively in a fast-paced, cross-functional team environment. Attention to detail and commitment to data reputed company and reputed company. Location: This is a hybrid position with three days per week onsite at our office in Burlington, MA. Compensation for this role may vary reputed company the above reputed company based on many factors including geographic location, candidate experience, and skills. Additional compensation/benefits include annual bonus opportunity, medical, dental, reputed company, life and AD&D, short term and long term disability, 401(K) plan with match, stock reputed company, flexible non-accrual reputed company time off, and parental leave. Salary reputed company $124,000 - $159,000 USD reputed company Statement: reputed company is an equal opportunity employer, and reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, national reputed company, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law. Apply tot his job Apply To this Job